Can selenium deficiency in Malawi be alleviated through consumption of agro-biofortified maize flour? Study protocol for a randomised, double-blind, controlled trial

Abstract

BackgroundMicronutrient deficiencies including selenium (Se) are widespread in Malawi and potentially underlie a substantial disease burden, particularly among poorer and marginalised populations. Concentrations of Se in staple cereal crops can be increased through application of Se fertilisers – a process known as agronomic (agro-) biofortification – and this may contribute to alleviating deficiencies. The Addressing Hidden Hunger with Agronomy (AHHA) trial aims to establish the efficacy of this approach for improving Se status in rural Malawi.MethodsA double-blind, randomised, controlled trial will be conducted in a rural community in Kasungu District, Central Region, Malawi. The hypothesis is that consumption of maize flour agro-biofortified with Se will increase serum Se concentration. We will recruit 180 women of reproductive age (WRA; 20–45 years) and 180 school-aged children (SAC; 5–10 years) randomised in a 1:1 ratio to receive either maize flour enriched through agro-biofortification with Se or a control flour not enriched with Se. Households will receive flour (330 g [i]capita[/i]-1 day-1) for 12 weeks. The primary outcome is Se concentration in serum (µg L-1). Serum will be extracted from venous blood samples drawn at baseline (prior to flour distribution) and end-line. Selenium concentration will be measured using Inductively Coupled Plasma Mass Spectrometry (ICPMS).DiscussionFindings will be communicated to policy stakeholders and participating communities and reported in peer-reviewed journals. This work was supported by the Bill & Melinda Gates Foundation, Grant Number OPP1181048

Voyage of selenium from environment to life: Beneficial or toxic?

“… 14 Se has a minute recommended dosage (55–200 μg/day) in humans wherein Se supports the function of endocrine, immune and cardiovascular systems; hence, low dietary Se intake is associated with Se deficiency diseases such as the endemic Keshan disease (cardiomyopathy) and Kashin–Beck disease (osteoarthritis), both of which are reported to occur in the low Se‐containing regions of China. Deficiency of Se, existing in many countries of the world such as Finland, United Kingdom, New Zealand, Malawi, parts of China, Tibet and Brazil, [ 126–129 ] is a serious problem. Interestingly, populations residing in Se‐lacking provinces of China show single‐nucleotide polymorphisms within genes encoding selenoproteins, suggesting that genetic adaptation has occurred in response to the content of Se present in the human diet.…”

“…The concentration of Se intake is very crucial in determining its beneficial or toxic outcome. 14 Kingdom, New Zealand, Malawi, parts of China, Tibet and Brazil, [126][127][128][129] is a serious problem. Interestingly, populations residing in Se-lacking provinces of China show single-nucleotide polymorphisms within genes encoding selenoproteins, suggesting that genetic adaptation has occurred in response to the content of Se present in the human diet.…”